510(k) K052947

SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE by Source Production & Equipment Co., Inc. — Product Code JAQ

K052947 is an FDA 510(k) premarket notification submitted by Source Production & Equipment Co., Inc. for the device "SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE". The FDA issued a decision of Substantially Equivalent on April 19, 2006. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Source Production & Equipment Co., Inc. has at least 6 other 510(k) clearances on record.